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Tenaya Stock Plunges After $60 Million Equity Offering
Benzinga· 2025-12-12 18:56
Tenaya Therapeutics, Inc. (NASDAQ:TNYA) stock is trading lower on Friday, with a session volume of 42.39 million compared to the average volume of 3.51 million as per data from Benzinga Pro. • Tenaya Therapeutics stock is feeling bearish pressure. What’s pressuring TNYA stock?On Thursday, Tenaya Therapeutics priced its underwritten public offering of 50 million units at $1.20 per unit for gross proceeds of $60 million. Each unit consists of one share and a warrant to purchase one share of common stock at an ...
Arcus Revamps Cancer Pipeline Following Trial Miss, Prioritizes Kidney Drug
Benzinga· 2025-12-12 18:35
Core Insights - Arcus Biosciences has announced the discontinuation of the Phase 3 STAR-221 study due to futility, following a recommendation from the Independent Data Monitoring Committee after an interim analysis of overall survival [1][2]. Study Discontinuation - The STAR-221 study evaluated the combination of anti-TIGIT antibody domvanalimab and anti-PD-1 antibody zimberelimab with chemotherapy against nivolumab plus chemotherapy for untreated patients with advanced gastric and esophageal cancers [2]. - The interim analysis revealed that the domvanalimab-based combination did not improve overall survival compared to nivolumab plus chemotherapy, with a similar safety profile and no new safety findings [3]. Future Directions - Arcus will focus its R&D efforts on casdatifan, a potential best-in-class HIF-2α inhibitor, which has shown strong single-agent activity in over 120 late-line clear cell renal cell carcinoma (ccRCC) patients in the ARC-20 Phase 1/1b study [5]. - Key milestones for casdatifan include additional analyses in early 2026, more mature combination data by mid-2026, and potential initiation of a Phase 3 trial in late 2026 [6][7]. Oncology Pipeline - Arcus is advancing quemliclustat, a small-molecule CD73 inhibitor, with the Phase 3 PRISM-1 trial in first-line metastatic pancreatic ductal adenocarcinoma having completed enrollment earlier this year, with results expected in 2027 [8]. Immunology and Inflammation Pipeline - The immunology and inflammation portfolio includes several oral small-molecule programs, with two candidates expected to enter clinical trials in the near future [10][11].
Arcus Biosciences Shares Drop 12% After Discontinuing Phase 3 STAR-221 Trial
RTTNews· 2025-12-12 17:57
Arcus Biosciences, Inc. (RCUS) is trading 11.50 percent lower at $22.25, down $2.89 on Friday, after announcing the discontinuation of its Phase 3 STAR-221 study conducted with Gilead Sciences. The stock opened at $21.15 and has traded between $20.35 and $24.00 so far on the New York Stock Exchange. The bid sits at $22.54 and the ask at $22.60, with volume at 4,426,823 versus an average of 1,561,846.Arcus shares are now trading well off their recent peak, within a 52-week range of $6.50 to $26.40. For comm ...
ImmunityBio Moves Closer To EU Approval For Bladder Cancer Therapy
Benzinga· 2025-12-12 17:00
Core Viewpoint - The European Medicines Agency (EMA) has recommended conditional marketing authorization for ImmunityBio's Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [1][4]. Group 1: Clinical Trial Results - A single-arm clinical trial involving 100 adults showed a complete response rate of 71%, with responses lasting up to 54+ months and an average duration of approximately 27 months [2]. - The complete response rates at 12 months and 24 months were 66% and 42%, respectively [3]. Group 2: Regulatory and Market Context - The conditional marketing authorization is part of an EU regulatory mechanism aimed at providing early access to medicines for unmet medical needs [4]. - Bladder cancer is the fifth-most common cancer and the seventh most frequently diagnosed cancer in men, with an estimated 200,000 new cases expected in 2025 [4]. - Approximately 75% of these patients (150,000) will have NMIBC, which is the most common form of bladder cancer [5]. Group 3: Next Steps and Market Reaction - ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy results to the EMA post-marketing [3]. - Following the EMA's recommendation, the opinion will be forwarded to the European Commission for final approval of EU-wide marketing authorization [6]. - ImmunityBio's shares increased by 2.74% to $2.25 at the time of publication [6].
MLTX Investor Deadline Alert: MoonLake (MLTX) Class Action Lawsuit - Hagens Berman Scrutinizing Nanobody Superiority Claims After 90% Plunge; December Lead Plaintiff Deadline Looms
Prnewswire· 2025-12-12 16:46
Issuer MoonLake Immunotherapeutics (MLTX) Class Period March 10, 2024 – September 29, 2025 Lead Plaintiff Deadline December 15, 2025 Stock Drop Event Stock fell from $61.99 to $6.24 (a 90% loss) on September 29, 2025, after VELA-2 trial failed its primary endpoint and efficacy was shown to be inferior to a competitor. Next Steps for MoonLake (MLTX) Investors: SAN FRANCISCO, Dec. 12, 2025 /PRNewswire/ -- Global plaintiffs' rights firm Hagens Berman reminds investors that the Lead Plaintiff Deadline in the se ...
Moderna 2026 Covid and RSV growth not enough to boost stock, Jefferies says
Proactiveinvestors NA· 2025-12-12 16:42
About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...
NVO Down 42% Year to Date: Is This an Indication to Sell the Stock?
ZACKS· 2025-12-12 16:40
Core Insights - Novo Nordisk (NVO) has faced significant challenges in 2025, with shares down 41.5% year to date despite resolving U.S. supply issues for its semaglutide-based products, Ozempic and Wegovy [1][9] - The company has cut its 2025 sales and operating profit growth outlook due to weaker-than-expected performance from Ozempic and Wegovy, intensified competition from Eli Lilly (LLY), foreign exchange impacts, and increased use of compounded semaglutide [2][9] - A major restructuring initiative has been announced, including the appointment of a new CEO and a reduction of approximately 9,000 employees, aiming for annualized savings of around DKK 8 billion by 2026 [3] Financial Performance - Ozempic and Wegovy generated DKK 152.5 billion in revenue during the first nine months of 2025, indicating their continued importance to NVO's financials [8] - Earnings estimates for 2025 have decreased from $3.66 to $3.57 per share, with 2026 estimates also declining from $3.91 to $3.65 [21] Competitive Landscape - Eli Lilly has emerged as a strong competitor, with its drugs Mounjaro and Zepbound generating combined sales of $24.8 billion in the first nine months of 2025, accounting for 54% of Eli Lilly's total revenues [11] - Smaller biotech firms are also entering the obesity treatment market, with Structure Therapeutics advancing its investigational candidate aleniglipron [5][25] Strategic Initiatives - Novo Nordisk is implementing strategic pricing changes for Wegovy and Ozempic to enhance demand and access, although this may lead to margin compression [4] - The company is expanding its pipeline with next-generation obesity treatments, including CagriSema and amycretin, and has submitted regulatory filings for new therapies in rare diseases and liver care [12][14][15] Market Position - Despite recent challenges, Novo Nordisk remains a dominant player in the diabetes and obesity care market, with a broad portfolio [7] - The stock is currently trading at a price/earnings ratio of 13.81, lower than the industry average of 16.59, indicating a potential undervaluation [18]
Kymera's Eczema Drug Gets Fast Track Designation in the United States
ZACKS· 2025-12-12 16:30
Core Insights - Kymera Therapeutics, Inc. (KYMR) received FDA Fast Track designation for KT-621, aimed at treating moderate to severe atopic dermatitis, which is the most common form of eczema [1][8] - KYMR's stock increased by 4.23% in after-hours trading following the announcement [1] - KT-621 is a first-in-class, once-daily oral degrader of STAT6, a key transcription factor in Type 2 inflammation [1] FDA Designation - The Fast Track designation from the FDA accelerates the development and review process for drugs addressing serious conditions and unmet medical needs, allowing for frequent interactions with the FDA during clinical development [2] Clinical Development - Positive results were reported from the phase Ib study, BroADen AD, where KT-621 showed effectiveness across various measures, including STAT6 degradation and safety [3] - A phase IIb study, BROADEN2, is ongoing with data expected by mid-2027, and a phase IIb study for asthma is planned to start in Q1 2026 [4] Financial Performance - Kymera closed an upsized underwritten public offering, raising $602 million by selling 8,050,000 shares at $86 per share, with gross proceeds of approximately $692.3 million [5] - The company's stock has surged 64.1% year to date in 2025, outperforming the industry gain of 17.7% [6][7] Pipeline and Collaborations - Kymera is utilizing targeted protein degradation (TPD) to develop drugs for significant health issues, with promising progress in its pipeline [9] - In June 2025, Kymera entered an exclusive agreement with Gilead Sciences to develop a novel molecular glue degrader program targeting CDK2 for oncology applications [10][11] - Kymera also collaborates with Sanofi to advance its pipeline, with a candidate targeting IRAK4 selected for clinical studies [12]
MLTX DEADLINE: Faruqi & Faruqi Reminds MoonLake Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of December 15, 2025 - MLTX
Prnewswire· 2025-12-12 16:21
Faruqi & Faruqi is a leading national securities law firm with offices in New York, Pennsylvania, California and Georgia. The firm has recovered hundreds of millions of dollars for investors since its founding in 1995. See www.faruqilaw.com. As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: Defendants made false and/or misleading statements, as well as failed to disclose ...
Wall Street Analysts Believe Schrodinger (SDGR) Could Rally 46.17%: Here's is How to Trade
ZACKS· 2025-12-12 15:56
Core Viewpoint - Schrodinger, Inc. (SDGR) has seen a 5.4% increase in share price over the past four weeks, closing at $18.13, with a potential upside of 46.2% based on Wall Street analysts' mean price target of $26.5 [1] Price Targets - The average of 10 short-term price targets ranges from a low of $18.00 to a high of $33.00, with a standard deviation of $5.46, indicating variability among analysts [2] - The lowest estimate suggests a decline of 0.7% from the current price, while the highest estimate indicates an 82% upside [2] Analyst Consensus and Earnings Estimates - Analysts are optimistic about SDGR's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which historically correlates with stock price movements [4][11] - The Zacks Consensus Estimate for the current year has increased by 6.4% over the past month, with one estimate rising and no negative revisions [12] Zacks Rank - SDGR holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [13] Caution on Price Targets - While price targets are a common metric for investors, relying solely on them can be misleading, as analysts may set overly optimistic targets due to business incentives [3][8][10]